Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation (RT-ID)
Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability
The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:
To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.
調査の概要
詳細な説明
Up to ten children with autism and co-occurring Intellectual Disability (ASD + ID) ages 8 to 12 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help children with ASD + ID calm their emotions. Participants will complete assessments at five time points:
Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Grayson Manley, RN
- 電話番号:816-816-6967
- メール:gmanley@cmh.edu
研究場所
-
-
Missouri
-
Kansas City、Missouri、アメリカ、64108
- 募集
- Children's Mercy
-
コンタクト:
- Grayson Manley, RN
- 電話番号:816-816-6967
- メール:gmanley@cmh.edu
-
主任研究者:
- Walker McKinney, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Child Participant Inclusion Criteria:
- Males, females, or non-binary youth between 8 and 12 years of age
- Confirmed diagnosis of Autism Spectrum Disorder (ASD)
- Confirmed diagnosis of Intellectual Disability
- Fluent in spoken English.
- Use of flexible phrase speech or greater
- Meeting clinically significant emotion dysregulation criteria
- Willing to participate in twice weekly 90-minute sessions
- Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
- Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant
Child Participant Exclusion Criteria:
- Initiation of new psychosocial intervention within 30 days prior to first day of treatment
- Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Caregiver Inclusion Criteria:
- Age ≥ 18 years
- Lives and cares for their child with ASD+ID for > 50% of the year
- Fluent in spoken English.
- Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Children with autism and co-occurring intellectual disability and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
|
Regulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions.
This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Autism with a co-occurring intellectual disability.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Emotion Dysregulation Inventory - Reactivity
時間枠:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
The Emotion Dysregulation Inventory consists of two subscales.
The investigators will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation.
Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinician Global Impressions - Improvement (CGI-I)
時間枠:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A trained, independent clinician will rate the CGI at T3 and T5.
The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Emotion Regulation Skills Test
時間枠:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
時間枠:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
Caregiver-report measures to measure change in internalizing symptoms.
For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Aberrant Behavior Checklist, 2nd Edition (ABC-2)
時間枠:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors.
Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Parenting Stress Index, 4th Edition, Short Form
時間枠:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system.
Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Caregiver and Child Readiness and Satisfaction Surveys
時間枠:From enrollment to end of follow up at 15 weeks
|
The investigators will assess acceptability as reflected in the average caregiver and child satisfaction rating measured using two study-specific measures.
Caregivers will complete the Caregiver Readiness and Satisfaction Survey and children will complete the Child Readiness and Satisfaction Survey.
|
From enrollment to end of follow up at 15 weeks
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協力者と研究者
協力者
捜査官
- 主任研究者:Walker McKinney, PhD、Children's Mercy
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00004069
- KL2TR002367 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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